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NCT00117312 · ClinicalTrials.gov registry record · Phase 2
Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
A Phase 2 study, sponsored by Ferring Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT00117312: Clinical Trial Phase 2 study, sponsored by Ferring Pharmaceuticals.
NCT00117312 is a Phase 2 study that was terminated before completion, run by Ferring Pharmaceuticals. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00117312, a Phase 2 study, was terminated before completion, sponsored by Ferring Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
Participants responding well in Study FE200486 CS06 (NCT00117949) were given the opportunity to continue treatment with degarelix under a clinical study until FE200486 was available on the market or until the study was discontinued. Study FE200486 CS06A was to provide knowledge of the long-term safety and tolerability of FE200486.
Primary Outcome
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \>3x ULN and ALT increases \>3x ULN with concurrently increased bilirubin \>1.5 ULN.
Interventions
- DRUG Degarelix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2002-10 |
| Est. Completion | 2005-11 |
| Phase | Phase 2 |
Why NCT00117312 stopped before completion
NCT00117312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Degarelix is the first listed.
NCT00117312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00117312 about?
NCT00117312 is a clinical study titled "Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients". Participants responding well in Study FE200486 CS06 (NCT00117949) were given the opportunity to continue treatment with degarelix under a clinical study until FE200486 was available on the market or until the study was discontinued. Study FE200486 CS06A was to provide knowledge of the long-term saf...
What is the current status of trial NCT00117312?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2002-10. Estimated completion is 2005-11.
What interventions are being tested in trial NCT00117312?
The interventions under investigation include: Degarelix (DRUG).
Who is sponsoring clinical trial NCT00117312?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00117312's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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